Medical Device Nonvisual Accessibility Act of 2025
This bill, the Medical Device Nonvisual Accessibility Act of 2025, would add a new nonvisual accessibility standard to the Federal Food, Drug, and Cosmetic Act (FD&C Act) for certain medical devices with digital user interfaces. Specifically, it would apply to “covered devices” that are Class II or III under FDA classification and have a user interface (such as screens or mobile apps) and are not intended only for health-care provider use or outside the home. The core requirement is that these devices’ nonvisual user interfaces be as effective for blind or low-vision users as for sighted users, preserving privacy, independence, and ease of use. The bill sets up a regulatory process: the FDA (in consultation with the Architectural and Transportation Barriers Compliance Board and input from blind/low-vision individuals) would publish proposed regulations within 1 year and a final rule within 2 years of enactment; the final rule would take effect 1 year after publication. It also provides a waiver pathway if compliance would cause a fundamental alteration to the product or undue hardship. In addition, the bill would establish training for manufacturers on the new standards. Enforcement would be through an adulteration provision, making noncompliant covered devices subject to FDA action beginning on the effective date. Overall, the measure aims to improve accessibility for blind and low-vision users of home-use medical devices with digital interfaces. For context, the bill’s findings emphasize the growing role of home medical devices, the accessibility gap for visually impaired users, and the potential for nonvisual features to improve safety and reduce waste or mistakes. Notes on terms: - Class II/III devices: FDA risk-based categories; Class II generally moderate risk, Class III higher risk; many devices require premarket review (e.g., 510(k) clearance, De Novo, or PMA). - 510(k): Premarket notification showing substantial equivalence to a legally marketed device. - Nonvisual accessibility: Access to information, interactions, and services without relying on vision, while preserving privacy and independence.
Key Points
- 1Standard and scope: Establishes a new nonvisual accessibility standard (Section 515D) for “covered devices” with a user interface, requiring equal access for blind/low-vision users in terms of information access, interactions, and services, with comparable privacy, independence, and ease of use.
- 2Covered devices and definitions: A device is covered if it is Class II or III, cleared under 510(k), or approved/authorized after the standard’s effective date, has a user interface, and is not solely for health care provider use or non-home settings.
- 3Waiver mechanism: The FDA may waive the standard for a covered device if clear and convincing evidence shows applying the standard would cause a fundamental alteration or undue hardship for the manufacturer.
- 4Regulatory timeline and training: The FDA, with input from the Accessibility Board and affected individuals, must issue proposed regulations within 1 year and final regulations within 2 years; the final rule becomes effective 1 year after publication. The Secretary must conduct training for manufacturers on the standard and compliance.
- 5Enforcement and adulteration: Beginning on the standard’s effective date, a covered device that does not meet the nonvisual accessibility standard (and has no waiver) would be considered adulterated under section 501(k) of the FD&C Act, giving FDA enforcement options.